NCT05811234Completed
A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults
An International, Prospective, Observational Cohort Study to Assess Patient Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults (PRO-SCALP)
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of Calcipotriene/Betamethasone Dipropionate (CAL/BDP) PAD cream in a real-world setting.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 291 (actual)
- First submitted
- 31 Mar 2023
- Start date
- 13 Jun 2023
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Almirall, S.A.
- Diseases
- Psoriasis
- NCT number
- NCT05811234
What you commit to
- Study type: Observational
- Participants enrolled: 291
- From 13 Jun 2023 to the primary completion date, 1 Oct 2024
- 37 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants previously treated with systemic drugs for psoriasis (conventional or biologic) within the last 12 weeks prior to inclusion.
- Concomitant systemic treatment with anti-psoriatic drugs.
- Concomitant treatment of any type for plaque psoriasis of the scalp.
Other illness
- Hypersensitivity to the active substances or to any of the excipients of CAL/BDP PAD cream (Wynzora®).
- Participants with viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.
Lab values
- Participants with known disorders of calcium metabolism.
Other
- Participants with severe plaque psoriasis, per physician global assessment.
- Participants with erythrodermic, exfoliative or pustular psoriasis.
- Pregnant or breastfeeding women, except when the potential benefit justifies the potential risk.
- Participants unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
- Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.
Who the study is looking for
- Adult (greater than or equal to \[\>=\] 18 years) male or female participants with mild-to-moderate plaque psoriasis of the scalp (defined as scalp-PGA score of 2 or 3 at baseline) with or without involvement of the trunk and limbs, and who may or may not have been previously treated (treatment-naive participants) with other anti-psoriatic therapies.
- Participants who have been prescribed CAL/BDP PAD cream (Wynzora®) treatment to manage plaque psoriasis of the scalp according to SmPC in routine clinical practice.
- Willingness and ability to participate in the study; participants must give their written consent to participate.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
- Patient- and clinician-reported outcomes of calcipotriol/betamethasone dipropionate PAD-cream for the treatment of adult patients with scalp psoriasis under real-world conditions: results from the prospective, noninterventional, multicentre PRO-SCALP study.Clin Exp Dermatol · 2026 · PMID 42052895
- Adherence to CAL/BDP PAD-Cream Influences Treatment Effectiveness and Preference in Scalp Psoriasis Under Real-Life Conditions: Results from the Prospective, Multicenter, Observational PRO-SCALP Study.Dermatol Ther (Heidelb) · 2026 · PMID 42573965
This page is information, not medical advice. Discuss any trial with your doctor.